Chloramphenicol Injection
»Chloramphenicol Injection is a sterile solution of Chloramphenicol in one or more suitable solvents.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C11H12Cl2N2O5.It may contain suitable buffers.
Packaging and storage— Preserve in single-dose or in multiple-dose containers.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparationas obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.2USP Endotoxin Unit per mg of chloramphenicol.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,1mLfrom each container being transferred directly to the membrane filter.
pHá791ñ: between 5.0and 8.0,in a solution diluted with water (1:1).
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Chloramphenicol.
Assay preparation— Transfer an accurately measured volume of Chloramphenicol Injection,equivalent to about 200mg of chloramphenicol,to a 100-mLvolumetric flask,add Mobile phaseto volume,and mix.Transfer 4.0mLof the resulting solution to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Filter this solution through a 0.5-µm or finer porosity filter.
Procedure— Proceed as directed for Procedurein the Assayunder Chloramphenicol.Calculate the quantity,in mg,of C11H12Cl2N2O5in each mLof the Injection taken by the formula:
2.5(C/V)(rU/rS),
in which Vis the volume,in mL,of Injection taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 428
Phone Number:1-301-816-8178